Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- HLDEngine, Trephine, Accessories, Gas-Powered1Product Code
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered2Product Code
- FCTHeadlight, Fiberoptic Focusing2Product Code
- FSRLight, Headband, Surgical2Product Code
- FTZLocator, Magnetic1Product Code
- HMQMarker, Sclera1Product Code
- HMRMarker, Ocular1Product Code
- HMSDrum, Eye Knife Test1Product Code
- HMXCannula, Ophthalmic1Product Code
- HMYKeratome, Battery-Powered1Product Code
- HMZTrabeculotome1Product Code
- HNASpud, Ophthalmic1Product Code
- HNBSpoon, Ophthalmic1Product Code
- HNCSpecula, Ophthalmic1Product Code
- HNDSpatula, Ophthalmic1Product Code
- HNESnare, Enucleating1Product Code
- HNFScissors, Ophthalmic1Product Code
- HNGRongeur, Lachrymal Sac1Product Code
- HNHRing, Ophthalmic (Flieringa)1Product Code
- HNIRetractor, Ophthalmic1Product Code
- HNJPunch, Corneo-Scleral1Product Code
- HNKProbe, Trabeculotomy1Product Code
- HNLProbe, Lachrymal1Product Code
- HNMNeedle, Ophthalmic Suturing1Product Code
- HNNKnife, Ophthalmic1Product Code
- HNOKeratome, Ac-Powered1Product Code
- HNPIntroducer, Sphere1Product Code
- HNQHook, Ophthalmic1Product Code
- HNRForceps, Ophthalmic1Product Code
- HNSExpressor1Product Code
- HNTErisophake1Product Code
- HNWDilator, Lachrymal1Product Code
- HNXDepressor, Orbital1Product Code
- HNYCystotome1Product Code
- HNZCurette, Ophthalmic1Product Code
- HOACompressor, Orbital1Product Code
- HOBClamp, Muscle, Ophthalmic1Product Code
- HOCClip, Iris Retractor1Product Code
- HODClamp, Eyelid, Ophthalmic1Product Code
- HOECaliper, Ophthalmic1Product Code
- HOFBurr, Corneal, Manual1Product Code
- HOGBurr, Corneal, Battery-Powered1Product Code
- HOHSpectacle, Operating (Loupe), Ophthalmic1Product Code
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)1Product Code
- HOZSponge, Ophthalmic2Product Code
- HPMLocator, Metal, Electronic2Product Code
- HPNMagnet, Permanent1Product Code
- HPOMagnet, Ac-Powered2Product Code
- HPPHeadlamp, Operating, Battery-Operated1Product Code
- HPQHeadlamp, Operating, Ac-Powered2Product Code
- HPSUnit, Cryophthalmic2Product Code
- HPYUnit, Electrolysis, Battery-Powered, Ophthalmic1Product Code
- HQAUnit, Cryotherapy, Ophthalmic2Product Code
- HQBPhotocoagulator And Accessories2Product Code
- HQCUnit, Phacofragmentation2Product Code
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2Product Code
- HQFLaser, Ophthalmic2Product Code
- HQOUnit, Cautery, Thermal, Ac-Powered2Product Code
- HQPUnit, Cautery, Thermal, Battery-Powered2Product Code
- HQQApparatus, Cautery, Radiofrequency, Battery-Powered2Product Code
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered2Product Code
- HQSBurr, Corneal, Ac-Powered1Product Code
- HRFEngine, Trephine, Accessories, Battery-Powered1Product Code
- HRGEngine, Trephine, Accessories, Ac-Powered1Product Code
- HRHTrephine, Manual, Ophthalmic1Product Code
- HRJTable, Instrument, Powered, Ophthalmic1Product Code
- HRKTable, Instrument, Manual, Ophthalmic1Product Code
- HRNUnit, Cryophthalmic, Ac-Powered2Product Code
- HROUnit, Electrolysis, Ac-Powered, Ophthalmic2Product Code
- HRPPen, Marking, Surgical1Product Code
- KYBLens, Guide, Intraocular1Product Code
- KYGDevice, Irrigation, Ocular Surgery1Product Code
- K010353MED-LOGICS DISPOSABLE ALK TUBING1Cleared 510(K)
- K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,1010251Cleared 510(K)
- K993591BLADEWORKS DISPOSABLE ALK TUBING1Cleared 510(K)
- K981116SOVEREIGN CATARACT EXTRACTION SYSTEM1Cleared 510(K)
- K980647EYE IRRIGATOR MODEL #20201Cleared 510(K)
- K974561MOISTAIR FLUID AIR TUBING SET1Cleared 510(K)
- K971173ML DISPOSABLE ALK TUBING1Cleared 510(K)
- K970161HEDGES CORNEAL WETTING PAK1Cleared 510(K)
- K954842D.O.R.C. VFI/VFE SYSTEM1Cleared 510(K)
- K945171DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE1Cleared 510(K)
- K940392PEREGRINE PIC MINIPULATOR1Cleared 510(K)
- K935226I/V POLE1Cleared 510(K)
- K935003ELECTRIC I/V POLE OR EIVP21Cleared 510(K)
- K925921MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE1Cleared 510(K)
- K924999AUTOPOLE REGULATOR SYSTEM1Cleared 510(K)
- K924052INFINITY MICRO IRRIGATOR1Cleared 510(K)
- K922996MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS1Cleared 510(K)
- K922180LEWICKY O.R.S. TUBING1Cleared 510(K)
- K915808AQUEOUS PARACENTESIS PIPET1Cleared 510(K)
- K914587GRIESHABER AIR/FLUID TUBING SET1Cleared 510(K)
- K904186SITE DIAPHRAGM CASSETTE1Cleared 510(K)
- K881518INFUSION HANDLE1Cleared 510(K)
- K881517B & B I/A HANDPIECE1Cleared 510(K)
- K881682ALCON SITE(R)-COMPATIBLE CASSETTE1Cleared 510(K)
- K880543UNI-PORT1Cleared 510(K)
- K871454MORGAN THERAPEUTIC LENS1Cleared 510(K)
- K861203MULTI-SPIKE1Cleared 510(K)
- K860544BACSTOP FILTER IRRIGATION SUPPLY KIT1Cleared 510(K)
- K861013ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)1Cleared 510(K)
- K853243VISITEC IRRIGATION CONTROL SYSTEM1Cleared 510(K)
- K845039OPERAID DISPOS. IRRIGATING KNIFE1Cleared 510(K)
- K841807OPERAID NUCLEUS1Cleared 510(K)
- K832787ELECATH HEPARIN COATED THERMAL DILUTION1Cleared 510(K)
- K831996MICRO SURGICAL HANDLE1Cleared 510(K)
- K821897LENS1Cleared 510(K)
- K820889ASPIRATOR/IRRIGATOR OR I/A UNIT1Cleared 510(K)
- K820680DISPOSABLE TUBING SETS1Cleared 510(K)
- K802332INTRAJECT1Cleared 510(K)
- K801822NU-VISION DISP. OPHTHALMIC DRESSING TRAY1Cleared 510(K)
- K760820NALGENE EMERGENCY EYE WASH1Cleared 510(K)
- LCCApplicator, Ocular Pressure2Product Code
- LPOGases Used Within Eye To Place Pressure On Detached Retina3Product Code
- LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser2Product Code
- LWLFluid, Intraocular3Product Code
- LXPPlug, Scleral2Product Code
- LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla2Product Code
- LZPAid, Surgical, Viscoelastic3Product Code
- MLZVitrectomy, Instrument Cutter2Product Code
- MMCDilator, Expansive Iris (Accessory)2Product Code
- MOECollagen Corneal Shield1Product Code
- MSRTubing, Replacement, Phacofragmentation Unit2Product Code
- MSSFolders And Injectors, Intraocular Lens (Iol)1Product Code
- MUSFluidic, Phacoemulsification/Phacofragmentation2Product Code
- MXOLaser, System, Phacolysis2Product Code
- MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal1Product Code
- MYDKeratome, Water Jet1Product Code
- NCEInjector, Capsular Tension Ring1Product Code
- NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered2Product Code
- NGYCannula, Trocar, Ophthalmic1Product Code
- NKXNeedle, Phacoemulsification, Reprocessed2Product Code
- NKYBlade, Keratome, Reprocessed1Product Code
- NLAKnife, Ophthalmic, Reprocessed1Product Code
- NVBIntraocular, Pressure Measuring Device3Product Code
- OHWBurr, Corneal, Battery Powered, Rust Ring Removal1Product Code
- OHXBurr, Corneal, Ac-Powered, Rust Ring Removal1Product Code
- OJKEye Tray2Product Code
- OOEOphthalmic Femtosecond Laser2Product Code
- OTZGraft Insertion Instrument For Endothelial Keratoplasty1Product Code
- PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered2Product Code
- PZGSurgical Eye Tray1Product Code
- QDVIol Tray1Product Code
- QDWPhaco Kit2Product Code
- QDYVitrectomy Kit2Product Code
- QGJCorneal Inlay Inserter Handle1Product Code
- QQQGuide And Positioner, Ophthalmic Drug Delivery Device1Product Code
- PYUSponge, Eyelid Cleaning, Powered1Product Code
- QUQKnife, Intraocular Pressure Lowering2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
LENS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K821897
- 510(k) Type
- Traditional
- Applicant
- MORTAN, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/5/1983
- Days to Decision
- 191 days